The Problem In the U.S., approximately 100,000 people are on the waiting list for lifesaving organ transplants. There is a severe shortage of human organs available for transplantation. Xenotransplantation offers a potential solution by using organs from other species, such as pigs. This project explores the ethical issues related to clinical trials involving genetically modified pig kidneys for human transplant recipients. The Approach To address this challenge, Dr. Gusmano and his colleagues from the Hastings Center, Northwestern University and Vanderbilt University: Conducted a survey with 142 kidney transplant candidates at two transplant centers. Conducted in-depth interviews with: 28 kidney transplant candidates at two transplant centers 28 transplant experts 23 Institutional Review Boards (IRBs) and other research ethics experts Informing Ethical Translation of Xenotransplantation Clinical Trial “Our research will help to address the ethical challenges faced by those conducting, governing and participating in pig kidney clinical trials.” - Michael Gusmano, PhD Short Term Impact Equip IRBs and clinical transplant teams with tools to navigate the ethical challenges of pig kidney clinical trials. Empower clinical trial participants with resources to make informed decisions. Longer Term Impact Provide ethical guidance to researchers and policymakers for xenotransplantation research. Enhance public understanding of the FDA’s expanded access/compassionate use program. Societal Impact Funding for this research supports vital information and ethical guidance for pig kidney clinical trials, which is essential for addressing the severe shortage of organs for patients on the waiting list. This study has societal benefits in the following areas: For more information visit https://health.lehigh.edu/research-partners or email INRSRCH@lehigh.edu 13 Community/Culture: Contribute to efforts to address the shortage of organs for patients with end-stage renal disease. Policy: Advocate for health care policies that promote the ethical conduct of xenotransplantation research. Education: Develop educational materials for IRBs, research teams, clinical trial participants and patients.
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